Pfizer Expands Chantix Recall

   By Josh Beckerman 
 

Pfizer Inc. has expanded its voluntary recall of its antismoking pill Chantix, also known as varenicline.

The company said in June that it has suspended distribution and recalled certain lots due to heightened levels of nitrosamines.

Pfizer has recalled 12 lots, adding that it hasn't received any reports of adverse events related to the recall.

The company said, "there is no immediate risk to patients taking this medication," and that "the health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity."

The U.S. Food and Drug Administration said Friday that to "ensure patient access to varenicline, FDA will not object to certain manufacturers temporarily distributing varenicline tablets containing N-nitroso-varenicline above FDA's acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels."

Write to Josh Beckerman at [e-mail]

(END) Dow Jones Newswires

July 19, 2021 19:03 ET (23:03 GMT)

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